FDA allows Ariad’s leukaemia drug back on the market

The FDA has lifted its suspension of the marketing of ponatinib (Iclusig), which had been agreed on October 31st “because of the risk of life-threatening blood clots and severe narrowing of blood vessels“.

The drug must now carry a boxed warning about these safety issues, with the indications being:

* T315I-positive chronic myeloid leukaemia (chronic phase, accelerated phase, or blast phase) or T315I-positive Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia, and

* Chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia or Ph+ acute lymphoblastic leukaemia for whom no other tyrosine-kinase inhibitor therapy is indicated.

“Commercial distribution of Iclusig will begin by mid-January, at which time we will deploy dedicated commercial and medical affairs teams in the US. In the meantime, patients will continue to receive Iclusig through the IND [investigational new drug] mechanism.

“We expect the commercialization of Iclusig to be cash-flow positive from the onset.”

Marty Duvall, executive vice president and chief commercial officer, Ariad.



Related news:

After brief halt, FDA allows sales of drug for cancer to resume (The New York Times).

Reference links:

Ariad announces US resumption of marketing and commercial distribution of Iclusig (ponatinib) in refractory Philadelphia-positive leukaemias (Ariad press release).

Iclusig (ponatinib): drug safety communication – increased reports of serious blood clots in arteries and veins (FDA safety alert with updates)

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